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Neuromuscular Blockade and Surgical Conditions

NCT01564576 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-03-28

No results posted yet for this study

Summary

The aim of the present study is to prospectively assess whether deep neuromuscular blockade (NMB) (zero response to train of four and a post tetanic count of no more than 10 responses using a nerve stimulator monitoring) until the end of surgery, followed by sugammadex (bridion®) reversal is superior to the present practice of gradual NMB reduction at the end of surgery followed by neostigmine (Prostigmin®, Vagostigmin®) reversal, in patients undergoing laparoscopic sleeve gastrectomy. The investigators hypothesize that providing deep NMB throughout the procedure creates better conditions for surgery, while reversal of deep NMBwith sugammadex (bridion®) will enable quick and full reversal of relaxation and fewer postoperative respiratory events as compared to neostigmine (Prostigmin®, Vagostigmin®)reversal. Participants will be followed for the duration of hospital stay, an expected average of 7 days.

Conditions

  • Morbid Obesity

Interventions

DRUG

Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)

Rocuronium dose will be adjusted to maintain a depth of NMB of zero response to train of four and a post tetanic count of no more than 10 responses. At the end of surgery patients will receive a single bolus dose of 4 mg/kg sugammadex according to ideal body weight + 40%12. Extubation will be performed when train-of-four ratios ≥ 0.9.

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Haim Berkenstadt, MD · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01564576 on ClinicalTrials.gov